Cleared Special

TransLoc 3D (K232878) - FDA 510(k) Clearance

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K232878 · Foundation Fusion Solutions, LLC (Dba Cornerloc) · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2023
Decision
29d
Days
Class 2
Risk

K232878 is an FDA 510(k) clearance for the TransLoc 3D. Classified as Sacroiliac Joint Fixation (product code OUR), Class II - Special Controls.

Submitted by Foundation Fusion Solutions, LLC (Dba Cornerloc) (Tulsa, US). The FDA issued a Cleared decision on October 17, 2023 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Foundation Fusion Solutions, LLC (Dba Cornerloc) devices

Submission Details

510(k) Number K232878 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 18, 2023
Decision Date October 17, 2023
Days to Decision 29 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
93d faster than avg
Panel avg: 122d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code OUR Sacroiliac Joint Fixation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3040
Definition Sacroiliac Joint Fusion
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Consultant

Watershed Idea Foundry
Jeffrey Brittan

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - OUR Sacroiliac Joint Fixation

All 99
Devices cleared under the same product code (OUR) and FDA review panel - the closest regulatory comparables to K232878.
Liberty SI Lateral Implant System
K231923 · Spinal Simplicity, LLC · Dec 2023
SOLACE Sacroiliac Fixation System
K233241 · Ht Medical, LLC Dba Xenix Medical · Oct 2023
REUNION Sacroiliac Joint Fusion System
K232211 · Astura Medical · Oct 2023
Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue® MAX™ + Invue Inset Anterior Cervical Plate System, and FacetFuse® Screw Fixation System
K232605 · Lesspine Innovations · Sep 2023
TiLink-P SI Joint Fusion System
K230857 · SurGenTec, LLC · Sep 2023
Integrity-SI® Fusion System
K230226 · OsteoCentric Technologies · Sep 2023